Toripalimab combined with definitive chemoradiotherapy in locally advanced oesophageal squamous cell carcinoma (EC-CRT-001): a single-arm, phase 2 trial.
Yujia Zhu, Jing Wen, Qiaoqiao Li...
https://pubmed.ncbi.nlm.nih.gov/36990609Actively Recruiting
Phase 2
Age: 70Years - 85Years
All Genders
ID06187597
Efficacy and Safety of Toripalimab After Concurrent Chemoradiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma: a Multicenter, Randomized, Phase II Trial
Led by Sun Yat-sen University · Updated on 2024-03-12
140
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
N
Nanfang Hospital, Southern Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of toripalimab, an anti-PD-1 antibody, after chemoradiotherapy for elderly patients with locally advanced esophageal squamous cell carcinoma (ESCC) who cannot have surgery. The study aims to improve survival and reduce recurrence, as many elderly patients have difficulty tolerating intravenous treatments and have a high rate of cancer returning after standard chemoradiotherapy. This phase II trial seeks to find a safer, more effective treatment option for patients aged 70 to 85 years. Patients will receive a combination of radiotherapy and oral S-1 chemotherapy concurrently. Then, participants are randomly assigned to either receive toripalimab as a consolidation therapy for up to 12 months (16 cycles) or to undergo routine follow-up without additional treatment. The radiotherapy is delivered as 54 Gy over 27 fractions in 5 to 6 weeks using intensity-modulated radiotherapy. The study compares outcomes between those receiving toripalimab and those who do not after completing chemoradiotherapy. Participants will be closely monitored through regular follow-ups for up to 36 months, with assessments including progression-free survival, overall survival, clinical response 13 to 16 weeks after radiotherapy, duration of response, and treatment-related side effects. Researchers will evaluate the safety and effectiveness of adding toripalimab to standard therapy, with the goal of improving long-term control of esophageal cancer in elderly patients. The total observation period includes up to three years from enrollment for outcome evaluation.
CONDITIONS
Brief Title
Consolidation of Toripalimab After Chemoradiotherapy in Elderly Esophageal Cancer (EC-CRT-007)
Who Can Participate
Age: 70Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically confirmed squamous cell carcinoma of the esophagus
- Locally advanced cancer without distant metastasis according to UICC TNM version 8
- Not suitable for surgery due to medical reasons or patient choice
- Age between 70 and 85 years at diagnosis
- No prior cancer therapy
- Estimated life expectancy greater than 6 months
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2
- No history of other concurrent or previous malignancies
- Adequate organ function meeting specific blood count and biochemical requirements
- Ability to understand the study and provide informed consent
You will not qualify if you...
- Previous treatment with anti-tumor therapies including chemotherapy, radiotherapy, surgery, or immunotherapy
- Presence of distant metastasis or esophageal fistula at diagnosis
- Known allergy or hypersensitivity to monoclonal antibodies or certain chemotherapeutic drugs
- Existing bleeding disorders
- Inability to provide informed consent due to psychological, social, or familial reasons
- Peripheral neuropathy of grade 2 or higher
- History of other malignancies except certain skin, cervical, or prostate cancers
- Poorly controlled diabetes over 10 years
- Severe dysfunction of heart, lung, liver, kidney, or blood diseases preventing chemoradiotherapy
- Active or history of autoimmune diseases or immunodeficiency including HIV
- History of interstitial lung disease or non-infectious pneumonia
- Recent or untreated active pulmonary tuberculosis
- Active hepatitis B or C infection beyond specified thresholds
AI-Screening
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Concurrent Chemoradiotherapy
Duration - 5 to 6 weeks
Participants receive definitive radiotherapy with intensity-modulated radiotherapy and concurrent S-1 chemotherapy.
Daily visits for radiotherapy sessions over 5-6 weeks; S-1 chemotherapy administered orally on days 1 to 14 and 29 to 42.
Consolidation Treatment
Duration - Up to 12 months
Participants in the study group receive toripalimab consolidation therapy every 3 weeks for up to 12 months (16 cycles). Participants in the control group receive routine follow-up without additional treatment.
Toripalimab group: visits every 3 weeks for up to 16 cycles; Control group: routine follow-up visits.
Follow-up
Duration - Up to 36 months
Participants are monitored for progression-free survival, overall survival, treatment response, and adverse events up to 36 months from enrollment.
Regular follow-up visits as scheduled by the study team.
Trial Site Locations
Total: 1 location
1
Mian Xi
Guangzhou, Guangdong, China, 510060
Actively Recruiting
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Research Team
M
Mian Xi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Efficacy of Concurrent Chemoradiotherapy With S-1 vs Radiotherapy Alone for Older Patients With Esophageal Cancer: A Multicenter Randomized Phase 3 Clinical Trial.
Yongling Ji, Xianghui Du, Weiguo Zhu...
https://pubmed.ncbi.nlm.nih.gov/34351356Comparison of concurrent chemoradiotherapy with radiotherapy alone for locally advanced esophageal squamous cell cancer in elderly patients: A randomized, multicenter, phase II clinical trial.
Yanxiao Liu, Zhiyong Zheng, Minghao Li...
https://pubmed.ncbi.nlm.nih.gov/35419831Effectiveness of S-1-Based Chemoradiotherapy in Patients 70 Years and Older With Esophageal Squamous Cell Carcinoma: A Randomized Clinical Trial.
Xin Wang, Weiming Han, Wencheng Zhang...
https://pubmed.ncbi.nlm.nih.gov/37195667